ICYMI: FDA Approves Galderma's Nemolizumab for Moderate to Severe Atopic Dermatitis in Patients 12 and Older

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Galderma announced Friday that the US Food and Drug Administration (FDA) has approved nemolizumab (Nemluvio) for the treatment of moderate to severe atopic dermatitis (AD) in patients aged 12 years and older with a history of inadequate response to topical therapies.¹ Nemolizumab is now indicated for combined use with topical corticosteroids and/or calcineurin inhibitors for this patient population.

This approval follows nemolizumab's prior FDA approval in August 2024 for prurigo nodularis.²

The approval was based on posiitve results from the phase III ARCADIA clinical program. This double-blind, placebo-controlled trial included 1,728 patients aged 12 years and older with moderate to severe AD. Patients received subcutaneous nemolizumab every 4 weeks alongside background topical corticosteroids, with or without topical calcineurin inhibitors, and were evaluated against placebo groups.

Researchers observed statistically significant improvement in achieving "clear" (0) or "almost clear" (1) skin at week 16, as well as a 75% reduction in eczema severity.

Significant reductions in itch were reported as early as week 1, and patients experienced meaningful reductions in sleep disturbance. Nemolizumab was well-tolerated, with a safety profile consistent with placebo.

Nemolizumab is the first monoclonal antibody targeting interleukin (IL)-31 receptor alpha, a pathway critical to itch and inflammation in AD. By inhibiting IL-31 signaling, nemolizumab provides a targeted approach to alleviate these symptoms and improve skin health.

Flemming Ørnskov, MD, MPH, CEO of Galderma, emphasized the innovation behind this approval.

"As just one example of our innovative, science-based pipeline, Nemluvio is an important and effective new treatment option for patients with atopic dermatitis, where unmet needs remain," Ørnskov said in a news release.¹ "Another key milestone on Galderma’s journey, this FDA approval will accelerate the ongoing growth of our US organization and our Therapeutic Dermatology Business, and underscores our commitment to delivering innovative first-in-class solutions to patients across the full spectrum of the fast-growing dermatology market."

Professor Jonathan Silverberg, MD, PhD, MPH, lead investigator and dermatology expert at George Washington University, highlighted the trial’s outcomes.

"Despite currently available treatment options, atopic dermatitis continues to have a massive impact worldwide, with patients not only burdened by intense itch and recurrent skin lesions, but also potentially several associated symptoms including sleep issues, pain, anxiety, and depression. I look forward to being able to offer this option to atopic dermatitis patients in my practice who are seeking relief from burdensome itch and lesions," he said.¹

References

1. Galderma receives US FDA approval for Nemluvio (nemolizumab) for patients with moderate-to-severe atopic dermatitis. News release. Galderma. December 14, 2024. Accessed December 16, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-patients-moderate-severe-atopic
2. Galderma receives US FDA approval for Nemluvio (nemolizumab) for adult patients living with prurigo nodularis. News release. Galderma. August 13, 2024. Accessed December 16, 2024. https://www.galderma.com/news/galderma-receives-us-fda-approval-nemluvior-nemolizumab-adult-patients-living-prurigo#:~:text=Zug%2C%20Switzerland%20%E2%80%93%20August%2013%2C,of%20adults%20with%20prurigo%20nodularis